Our partner Test Facilities can provide the full range of toxicity studies to support the drug development in rodents and non-rodents (rabbits, dogs, minipigs, marmosets and NHP) according to the international regulatory requirements and animal welfare legislation. General Toxicity Dose Range Finding and Maximum Tolerated Dose studies Single dose and preliminary TK Subacute (4wks), chronic studies…
We offer coordinated drug development programs providing our pharmaceutical clients an optimized service in terms of speed and cost effectiveness. Testing programs are tailored on the specific requirements of each test drug. The typical testing program according to ICH Guidelines is usually completed in 6-7 months and include: Acute toxicity studies in rodents (2 species…
We can offer a complete range of services for the biological evaluation of medical devices according to ISO 10993 and USP requirements. Biocompatibility Testing of Medical Devices Cytotoxicity Sensitization Irritation Systemic Toxicity Subchronic Toxicity Genotoxicity Pyrogenicity Implantation Hemocompatibility Chronic Toxicity Microbiological Testing of Medical Devices Test for Sterility Endotoxins Bioburden Test for Specified Microorganisms/Microbial Limit…
Methods to be employed in molecular design, impurity qualification, toxicological and environmental risk assessment (ERA). A computational toxicology assessment should be performed using QSAR (Quantitative structure–activity relationship) methodologies that predict the outcome of a bacterial mutagenicity assay. Two QSAR prediction methodologies that complement each other should be applied. One methodology should be expert rule-based and…
Expert Systems DEREK: Expert system for the prediction of toxicity (genotoxicity, carcinogeneticy, skin sensitization, …) METAPC: Windows based Metabolism and Biodegradation Expert System METEOR: Expert system for the prediction of metabolic transformations OncoLogic: Rule based expert system for the prediction of carcinogenicity Data Driven Systems Iazar: Open source inductive database for the prediction of chemical…
